Amantadine and Temporal Discrimination in Patients With T... | NCT00800514

Studies
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

NCT00800514

Sponsor

Wake Forest University Health Sciences

Status

Withdrawn

Last Update Posted

Apr 27, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury

Interventions

amantadine
amantadine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal investigator took a position at another institution. No subjects enrolled.

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Dec 1, 2008

First Submission Date that Met QC Criteria

Dec 1, 2008

First Posted Date

Dec 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2022

Last Update Posted Date

Apr 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
active	Experimental		Drug: amantadine

Name	Type	Description	Arm Group Labels	Other Names
amantadine	Drug	amantadine twice daily	active
amantadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure is the Interval Bisection Timing Task.		12 -16 months

Secondary Outcomes

Measure	Description	Time Frame
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).		12-16 moths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device).

Exclusion Criteria:

Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder)
Substance use disorder
Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes)
Seizures
Smoking one or more packs of cigarettes per day
If you are pregnant or breastfeeding, or plan to become pregnant during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oleg V. Tcheremissine, MD	Carolians HealthCare System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHS-Behavioral Health Research		Charlotte	North Carolina	28211	United States

Label	URL
Click here for more information about this study and CHS	View source

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000547	Amantadine

Ancestor Terms

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided